Danicopan Side Effects

Applies to danicopan: oral tablet.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding;

• chest discomfort, wheezing, dry cough or hack, rapid weight loss; or

• symptoms of meningitis--headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness.

Your condition may get worse if you stop taking this medicine. Tell your doctor if you have symptoms of low red blood cells (anemia) such as pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• abnormal liver function tests;

• high cholesterol; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to danicopan: oral tablet.

General

The most common adverse reaction occurring in 10% of patients or greater was headache.^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Gastrointestinal

Common (1% to 10%): Vomiting

Hepatic

Very common (10% or more): Increased ALT (14%)

ALT elevations greater than 3 times the upper limit of normal (3 x ULN) and 5 x ULN or less occurred in 9% of treated patients.

ALT elevations greater than 5 x ULN and 10 x ULN or less occurred in 5% of treated patients.

Metabolic

Very common (10% or more): Grade 1 hypercholesterolemia (30%), LDL cholesterol increased greater than 130 mg/dL and up to 160 mg/dL (13%)

Common (1% to 10%): LDL cholesterol increased greater than 160 mg/dL and up to 190 mg/dL

Frequency not reported: Increased serum triglycerides, increased total cholesterol, increased LDL cholesterol

Nervous system

Very common (10% or more): Headache (11%)

Other

Common (1% to 10%): Pyrexia, pain in extremity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer